Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Recruiting now · Not applicable
Conditions studied: Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy, Degenerative Spondylolisthesis, Instability Lumbar Spine
In brief
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results. The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.
Key facts
- Study ID
- NCT06320899
- Run by
- SpineSave AG
- People needed
- 126
- Starts
- 2024-06-04
- Expected to finish
- 2031-08-31
- Last updated by the study team
- 2024-06-25
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
- signed informed consent of participant
- confirmation of the participant that the attendance of follow-up visits are intended
- Body-Mass-Index < 32
- Pedicle screw axis distance < 30mm
- one or more of the following indications:
- (dynamic) stenosis in the spinal canal
- neuroforaminal stenosis
- facet joint syndrome / spondylarthrosis
- discopathy (recurrent disc hernia)
- degenerative spondylolisthesis (Meyerding <1)
- instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)
You may not qualify if…
- missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible
- damaged structural tissue, e.g. due to a bone fracture
- application to the thoracic or cervical spine
- pronounced idiopathic scoliosis
- spondylolisthesis > Meyerding grad 1
- isthmic spondolylysis
- bone tumor
- osteochondrosis modic type I, II or III
- osteoporosis, which could impair screw anchoring
- history with third party implants
- patients with an active local or systemic infection
- known allergy to titatnium alloys
- skeleton in growth (epiphyseal joints not closed)
- severe muscular neuronal or vascular disease
- immunosuppresive therapy
- long-term therapy with cortisone
- heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics
- chronic pain patients
- incapable of judgment or emergency situation
- implantation during pregnancy
Where it is running
- Spital Aarberg — Aarberg, Switzerland (enrolling)
- Hirslanden Klinik Linde — Biel, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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